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首页> 美国政府科技报告 >Federal Register Volume 61 No. 195, Monday, October 7, 1996 Rules andRegulations. Part 7. Department of Health and Human Services, Food and Drug Administration. 21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Fi
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Federal Register Volume 61 No. 195, Monday, October 7, 1996 Rules andRegulations. Part 7. Department of Health and Human Services, Food and Drug Administration. 21 CFR Parts 808, 812, and 820 Medical Devices; Current Good Manufacturing Practice (CGMP); Fi

机译：联邦登记册第61卷第195号，1996年10月7日，星期一规则和规定。第7部分。健康与人类服务部，食品药品管理局。 21 CFR parts 808,812和820医疗器械;现行良好生产规范（CGmp）;网络连接

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The Food and Drug Administration (FDA) is revising the current good manufacturingpractice (CGMP) requirements for medical devices and incorporating them into a quality system regulation. The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. This action is necessary to add preproduction design controls and to achieve consistency with quality system requirements worldwide. This regulation sets forth the framework for device manufacturers to follow and gives them greater flexibility in achieving quality requirements.

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